Trials / Terminated
TerminatedNCT03811951
Neuro Biomarkers of Smoking Behavior
Neurologic Biomarkers of Smoking Behavior
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 4 (actual)
- Sponsor
- University of Illinois at Chicago · Academic / Other
- Sex
- All
- Age
- 21 Years – 40 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to evaluate cognition in smokers and nonsmokers. It involves administration of intranasal insulin (Novolin R), an investigational medication followed by a brief non-invasive cognitive test. All participants will receive both Novolin R and placebo in two separate testing sessions.
Detailed description
This program of research focuses on identifying neurologic biomarkers of smoking behavior in order to develop individualized smoking cessation aids. The intranasal insulin administered is an investigational drug and has been granted IND status by the FDA (IND#129432). During the times of drug effects, the investigators will evaluate a biomarker using computerized tasks. Non-smokers and smokers will participate in two testing sessions where the biomarker will be critically evaluated after administration of intranasal insulin and compared to the cognitive processes elicited by placebo administration.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Novolin R | Novolin R is a sterile, clear, aqueous, and colorless solution that contains human insulin (rDNA origin) 100 units/mL, glycerol 16 mg/mL, metacresol 3 mg/mL, zinc chloride approximately 7 mcg/mL and water for injection. The pH (potential Hydrogen) is adjusted to 7.4. Hydrochloric acid 2N (concentration) or sodium hydroxide 2N may be added to adjust pH. Novolin R vials are latex-free. The drug substance is being purchased from McKesson. |
Timeline
- Start date
- 2018-09-12
- Primary completion
- 2019-09-27
- Completion
- 2019-09-27
- First posted
- 2019-01-22
- Last updated
- 2021-03-02
- Results posted
- 2021-03-02
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03811951. Inclusion in this directory is not an endorsement.